Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
As current study is conducted to provide additional information regarding safety and efficacy Bydureon, exenatide once weekly for injectable suspension, in the Korean population open label, non-comparative, multi-centre design is used.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bydureon | Experimental | exenatide once weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bydureon | Biological | exenatide once weekly |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs) | was to estimate the incidence rates of adverse events (AEs) and serious adverse events (SAEs) in patients who are treated with 2 mg exenatide once weekly for type 2 diabetes mellitus in the normal clinical practice setting over a period of 12/24 weeks for long-term surveillance. | baseline and 12/24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment) | baseline and 12/24 weeks |
| Change in Fasting Plasma Gloucose |
Not provided
Inclusion Criteria:
Male or female, 19-75 years of age
diagnosed with type 2 diabetes mellitus
Patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies;
Exclusion Criteria:
Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following medications:
diagnosed with type 1 diabetes mellitus or diabetic ketoacidosis;
type 2 diabetes by beta-cell dysfunction requiring insulin treatment
Has ever used exenatide
Pregnant or breast feeding patients
Hepatic disease (defined by aspartate or alanine transaminase >3.0 times the upper limit of normal
End-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/min)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Busan | 49241 | South Korea | |||
| Research Site |
115 subjects were participated: 5 failed screening without treatment with the study drug.
Participants recruited from 15 hospitals in South Korea between Jan 2016 and Jul 2016.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 12/24 Weeks Treatment | Exenatide 2mg / 12/24 weeks treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Change in Fasting plasma gloucose at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
| baseline and 12/24 weeks |
| Change in Body Weight | Change in body weight at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment) | baseline and 12/24 weeks |
| Change in Vital Sign | Change in vital sign at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment) | baseline and 12/24 weeks |
| Evaluation of "Subjective Improvement of Main Indication" | "Subjective improvement of main indication" will be assessed as "improved," "slightly improved," "unchanged," "aggravated," or "unable to evaluate." | baseline and 12/24 weeks |
| Daegu |
| 700-712 |
| South Korea |
| Research Site | Daejeon | 35015 | South Korea |
| Research Site | Gwangju | 61469 | South Korea |
| Research Site | Incheon | 405-760 | South Korea |
| Research Site | Seongnam-si | 13620 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| Research Site | Seoul | 06591 | South Korea |
| Research Site | Seoul | 08308 | South Korea |
| Research Site | Seoul | 130-872 | South Korea |
| Research Site | Suwon | 16499 | South Korea |
| Research Site | Wŏnju | 26426 | South Korea |
| COMPLETED |
|
| NOT COMPLETED |
|
|
104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 12/24 Weeks Treatment | Exenatide 2mg / 12/24 weeks treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs) | was to estimate the incidence rates of adverse events (AEs) and serious adverse events (SAEs) in patients who are treated with 2 mg exenatide once weekly for type 2 diabetes mellitus in the normal clinical practice setting over a period of 12/24 weeks for long-term surveillance. | Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. | Posted | Number | 95% Confidence Interval | percentage of participants | baseline and 12/24 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change in HbA1c | Change in HbA1c at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment) | Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. Of 104 subjects, 1 subject who failed to receive the efficacy analysis was excluded, and 103 were included in the efficacy set. | Posted | Mean | Standard Deviation | percentage of Hba1c | baseline and 12/24 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Plasma Gloucose | Change in Fasting plasma gloucose at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment) | Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. Of 104 subjects, 1 subject who failed to receive the efficacy analysis was excluded, and 103 were included in the efficacy set. | Posted | Mean | Standard Deviation | mg/dL | baseline and 12/24 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Body Weight | Change in body weight at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment) | Of 110 subjects, 104 were included in the safety set with 5 subjects of non-treatment with the study drug, 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. | Posted | Mean | Standard Deviation | kg | baseline and 12/24 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Vital Sign | Change in vital sign at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment) | Of 110 subjects, 104 were included in the safety set with 5 subjects of non-treatment with the study drug, 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. | Posted | Mean | Standard Deviation | mmHg | baseline and 12/24 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Evaluation of "Subjective Improvement of Main Indication" | "Subjective improvement of main indication" will be assessed as "improved," "slightly improved," "unchanged," "aggravated," or "unable to evaluate." | Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. Of 104 subjects, 1 subject who failed to receive the efficacy analysis was excluded, and 103 were included in the efficacy set. | Posted | Number | participants | baseline and 12/24 weeks |
|
|
12 weeks / 24 weeks
Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 12/24 Weeks Treatment | Exenatide 2mg / 12/24 weeks treatment | 4 | 104 | 55 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neuroendocrine tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Acute gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Pelvic inflammatory disease | Infections and infestations | Non-systematic Assessment |
| ||
| Hyperglycemia including diarrhea | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. |
| |
| Injection site nodule | General disorders | Non-systematic Assessment | Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. |
| |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. |
| |
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment | Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. |
| |
| injection site pruritus | General disorders | Non-systematic Assessment | Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. |
| |
| Dizziness | Nervous system disorders | Non-systematic Assessment | Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. |
| |
| Headache | Nervous system disorders | Non-systematic Assessment | Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment | Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. |
| |
| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment | Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. |
|
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hyun Jung Kang / Local Study Leader | Astrazeneca, Korea | 82 2 2188 0846 | 0846 | hyunjung.kang@astrazeneca.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
Not provided
Not provided
|
|
|
|
|